In this study of patients with atrial fibrillation and at least one additional risk factor for stroke, Eliquis met the primary efficacy objective of non-inferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism.

The drug met the key secondary endpoints of superiority on efficacy and on International Society on Thrombosis and Hemostasis major bleeding compared to warfarin.

Eliquis, a new oral direct Factor Xa inhibitor, is being developed by the alliance of BMS and Pfizer.

The companies expect to submit regulatory filings in atrial fibrillation in the US and Europe in the third or fourth quarter of 2011.

The detailed results of the ARISTOTLE study will be presented on August 28 at the European Society of Cardiology Congress 2011 in Paris.